Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
19 Sep. 1991 - 22 Sep. 1991
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report date:
1991

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
: Experiment was conducted under occlusive conditions
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Pielik 85 SP or 2,4-D sodium salt
- Physical state: white powder with an intense, characteristic smell
- Analytical purity: 94%
- Impurities (identity and concentrations): Chlorphenols expressed as 2,4-D Chlorphenol (0.3%); Substances insoluble in water (0.01%)
- Purity test date: 11th July 1991 (Certificate No. 1046/PK 91)
- Melting temperature of the 2,4-D acid: 139°C

Test animals

Species:
rabbit
Strain:
other: New Zealand
Details on test animals or test system and environmental conditions:
TEST ANIMALS
females
- Source: Rabbits Breeding S-52, Zator
- Age at study initiation: 3 - 6 months
- Weight at study initiation: 3,5 kg (mean)
- Housing: individually in cages (80 x 80 x 60 cm)
- Diet: granulated standard food and hay (Toxic impurities were below the limits of the FDA), both ad libitum
- Water: :ad libitum (drinking water quality)
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 4°C

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
Duration of treatment / exposure:
4h
Observation period:
1h, 24h, 48h and 72h
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: clipped dorsal trumk of the animals
- Type of wrap if used: gauze patch holding in place with non-irritating tape; fixation with an occlusive dressing

SCORING SYSTEM:
According to the OECD guideline No.404 (Table: grading of skin reactions)
TEST SITE


Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
of animals #1, 2 and 3
Time point:
other: average 24, 48 and 72h
Score:
0
Max. score:
4
Reversibility:
other: No effects observed
Irritation parameter:
edema score
Basis:
mean
Remarks:
of animals # 1, 2 and 3
Time point:
other: average 24, 48 and 72h
Score:
0
Max. score:
4
Reversibility:
other: No effects observed
Irritant / corrosive response data:
After patch removal there were no signs of erythema and edema at all time-points

Any other information on results incl. tables

Table 1: Pielik 85 SP – Evaluation of the skin reaction

Skin reaction

Rabbit No.

Irritation scores after

24 h

48 h

72 h

Erythema

1

2

3

0

0

0

0

0

0

0

0

0

Edema

1

2

3

0

0

0

0

0

0

0

0

0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information